FDA.reportPublic FDA data

Aquaphor

Manufacturer
Physicians Total Care, Inc.
Effective date
2012-05-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:32:06

Label at a glance#

ProductAquaphor
Active ingredientPetrolatum
Label structure12 sections

Indications and uses

Uses • temporarily protects minor: • cuts • scrapes • burns • temporarily protects and helps relieve chapped or cracked skin and lips • helps protect from the drying effects of wind and cold weather Directions Apply as needed

Dosage and administration

For the pharmacist: Aquaphor provides an ideal base for compounding smooth, stable emulsions. It is highly miscible with aqueous solutions and oil based substances.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 41%

PURPOSE

OTC - PURPOSE SECTION

Skin protectant ointment

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Uses
• temporarily protects minor: • cuts • scrapes • burns
• temporarily protects and helps relieve chapped or cracked
skin and lips
• helps protect from the drying effects of wind and
cold weather

Directions Apply as needed

WARNINGS

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product do not get into eyes

OTC - DO NOT USE SECTION

Do not use on • deep or puncture wounds • animal bites
• serious burns

OTC - STOP USE SECTION

Stop use and ask a doctor if • condition worsens
• symptoms last more than 7 days or clear up and occur
again within a few days

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Mineral Oil, Ceresin, Lanolin Alcohol

QUESTIONS

OTC - QUESTIONS SECTION

Questions or comments? 1-800-227-4703

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

For the pharmacist: Aquaphor provides an ideal base for
compounding smooth, stable emulsions. It is highly miscible
with aqueous solutions and oil based substances.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aquaphor
OINTMENT

Skin Protectant

Ideal for Compounding

Dermatologist Recommended

SEVERELY DR Y SKIN TREATMENT
Clinically proven to restore smooth, healthy skin

NET WT
14 oz
396 g

label
label

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma        74146

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052954Aquaphor 41 % Topical OintmentPSN1
725145petrolatum 41 % Topical OintmentPSN1
1052954petrolatum 0.41 MG/MG Topical Ointment [Aquaphor]SBD1
725145petrolatum 0.41 MG/MG Topical OintmentSCD1
1052954Aquaphor 0.41 MG/MG Topical OintmentSY1
1052954Aquaphor 41 % Topical OintmentSY1
725145petrolatum 41 % Topical OintmentSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-5870-02019-09-24C16284748780-19350213a-47c9-c013-e053-90daa90a1393dddcbb2e-7ade-4b05-bf19-229946e1ac26

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-5870-0Aquaphor396 g in 1 JAROINTMENT3961

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-5870AQUAPHOR (PETROLATUM) OINTMENT [PHYSICIANS TOTAL CARE, INC.]11 package rows20120525_dddcbb2e-7ade-4b05-bf19-229946e1ac26.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-5870-0GM - Gram54868-587008c4fc51-66e5-4838-bedd-8d41520ddb8812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PetrolatumACTIVE INGREDIENT4T6H12BN9U1
PetrolatumACTIVE MOIETY4T6H12BN9U1
CERESININACTIVE INGREDIENTQ1LS2UJO3A1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HE1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54868-587054868-5870-0
10356-100

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Petrolatum4T6H12BN9UACTIB
MINERAL OILT5L8T28FGPIACT
CERESINQ1LS2UJO3AIACT
LANOLIN ALCOHOLS884C3FA9HEIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LANOLIN ALCOHOLSLANOLIN ALCOHOLS884C3FA9HEOINTMENT / TOPICAL452 mgExact identifier — unii+route+dosage form
CERESINCERESINQ1LS2UJO3AOINTMENT / TOPICAL1097 mgExact identifier — unii+route+dosage form
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii+route+dosage form

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aquaphor OriginalPETROLATUMBeiersdorf Incd38ec874-7b8c-4b9b-92b6-286278bb67f32025-12-15WarningsExact identifier
ndc (product): 10356-100
b6744211-555b-4401-9b41-d503e9465ac2dddcbb2e-7ade-4b05-bf19-229946e1ac262012-05-21WarningsExact identifier
spl id: b6744211-555b-4401-9b41-d503e9465ac2
spl set id: dddcbb2e-7ade-4b05-bf19-229946e1ac26

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.